ISO 13485:2003 & FDA QSR (21 CFR 820) Manual, Procedures and Forms

This ISOXpress ISO 13485:2003 and FDA QSR (21 CFR 820) Template Documentation was originally published in 1996. It was the first template quality system documentation for the medical device industry. Now in its third edition, and with over 3,000 copies sold, it is by far the most popular and proven package on the market. The templates helped thousands of companies achieve ISO 13485 registration and/or FDA QSR compliance.

ISOXpress ISO 13485 Manual and Procedures package consists of 54 Microsoft Word files containing a quality manual, 34 operational procedures and forms. It covers both ISO 13485:2003 and FDA QSR (21 CFR Part 820) requirements, and thus fully complies with both the international and US FDA regulations. It defines a quality system that is simple, intuitive, and free from excessive paperwork, making it easy to operate and maintain.

There is also an implementation tutorial to help you edit and customize the documentation to fit your company. It comes in the form of extensive notes and tips inserted directly into the documents. These notes (in blue italic font) identify and explain the requirements which are being addressed in the particular section of the document, alert you to sections where you may need to make changes, and discuss alternative approaches and solutions that may be more suitable for particular types of products, processes or companies. It is like having a consultant by your side, anticipating your questions and helping you in real time as you customize the documentation.

This ISOXpress ISO 13485:2003 and FDA QSR (21 CFR 820) Quality Manual, Procedures and Forms is intended for quality managers, consultants and ISO 13485 teams that need to implement or update existing ISO 13485 and/or FDA QSR (21 CFR 820) quality systems.

The ISOXpress ISO 13485:2003 and FDA QSR (21 CFR 820) Template Documentation comes on a CD-Rom with 54 Microsoft Word files (quality manual, 34 procedures and forms) and a license to implement in one company. They can be integrated into the ISOXpress Document Control and ISO Management software, and can be used together with ISO 13485 internal audit and gap analysis checklist, ISO 13485 training materials and Medical Device Risk Analysis Manual (ISO 14971 Hazard Analysis Process). .These products can be purchased together in our ISOXpress Complete Package.